Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity

NCT ID: NCT07319975

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-29
• Study Completion Date: 2026-12-31

Brief Summary

Obesity is a growing global health problem that affects people of all ages. It can lead to serious health issues such as cardiovascular disease, insulin resistance, inflammation, and reduced physical function. New medications, including GLP-1 receptor agonists like semaglutide and dual GLP-1/GIP agonists like tirzepatide, have been shown to help people lose significant weight. However, some of this rapid weight loss may come from a reduction in muscle mass rather than fat. Losing muscle can lower physical performance, impair metabolic health, and increase the risk of developing sarcopenic obesity. This study aims to compare the effects of pharmacological treatment alone with a combined treatment program that includes both medication and exercise in individuals with obesity. The primary objective is to evaluate how these two approaches influence body composition.

The secondary objective is to examine the effects of pharmacological treatment versus combined treatment on cardiometabolic markers, peripheral muscle strength, functional capacity, respiratory function, respiratory muscle performance, and physical activity levels. The study seeks to determine whether adding structured exercise to medication can provide additional health benefits beyond weight loss.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ARM 1-Semaglutide

Drug: Semaglutide

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

They will use only semaglutide.

ARM 3-Semaglutide + Exercise

Group Type: EXPERIMENTAL

Semaglutide+Exercise

Intervention Type: BEHAVIORAL

This group will engage in exercise and receive semaglutide therapy."

ARM 4-Tirzepatide + Exercise

Group Type: EXPERIMENTAL

Tirzepatide+Exercise

Intervention Type: BEHAVIORAL

This group will engage in exercise and receive tirzepatide therapy."

ARM 2-Tirzepatide

Drug: Tirzepatide

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

They will use only tirzepatide.

Interventions

Semaglutide

They will use only semaglutide.

Intervention Type: DRUG

Tirzepatide

They will use only tirzepatide.

Intervention Type: DRUG

Tirzepatide+Exercise

This group will engage in exercise and receive tirzepatide therapy."

Intervention Type: BEHAVIORAL

Semaglutide+Exercise

This group will engage in exercise and receive semaglutide therapy."

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Those between the ages of 25 and 60 years
• Those with a body mass index (BMI) between 30 and 40 kg/m2 according to the World Health Organization (WHO) classification
• Individuals who volunteered to participate in the study

Exclusion Criteria

• Individuals with a BMI greater than 40 kg/m2 according to the WHO classification
• Individuals with a Charlson comorbidity index score of 3 or higher
• Uncontrolled arrhythmia, hypertension, heart failure, diabetes, and unstable angina pectoris
• Cooperation impairment, orthopedic, and neurological problems that may interfere with evaluation and treatment
• Individuals with a history of lower extremity injury or surgery in the last six months
• Diagnosed with diabetes and complications such as nephropathy, retinopathy, and neuropathy
• Individuals with concomitant chronic respiratory disease
• Individuals with acute infections
• Individuals with middle ear pathologies (such as tympanic membrane rupture, otitis media)
• Individuals with a history of spontaneous or trauma-related pneumothorax
• Smokers
• Pregnancy
• Individuals with a STOP-bang score of 3 or higher
• Individuals on a structured diet program for weight loss during the study period
• Individuals who have had endoscopic intervention and/or bariatric surgery within the last year

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biruni University

OTHER

Sponsor Role: collaborator

Istanbul University

OTHER

Sponsor Role: collaborator

Istanbul Galata University

OTHER

Sponsor Role: lead

Responsible Party

Safak Yigit

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Safak Yigit, PhD

Role: CONTACT

safak.yigit@galata.edu.tr

+905309634910

Facility Contacts

Buket Akinci, Associate Professor, PhD

Role: primary

bakinci@biruni.edu.tr

+905056415692

Other Identifiers

2025-GLP1-OBESITY

Identifier Type: -

Identifier Source: org_study_id